Abstract: PUB132
Clinical Performance of the New Plasma Filter PX2 in Therapeutic Plasma Exchange
Session Information
Category: Dialysis
- 801 Dialysis: Hemodialysis and Frequent Dialysis
Authors
- Schmitt, Jana, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany
- Gillen, Christine, Fresenius Medical Care Adsorber Tec GmbH, Krems, Austria
- Erlenkoetter, Ansgar, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany
- Rauber, Lena, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany
- Derlet-Savoia, Anja, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany
- Stauss-Grabo, Manuela, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany
Background
Therapeutic plasma exchange (TPE) belongs to field of therapeutic apheresis and therefore the recommendations of the American Society for Apheresis (ASFA) are applied.
TPE is a method for extracorporeal blood treatment designed to remove high molecular weight substances, such as immunoglobulins and pro-inflammatory factors. TPE is indicated for diseases which are associated with increased concentrations of plasma components and where a rapid depletion of these molecules mitigates or stops a pathogenic process. The usual dose of TPE is equivalent to 1.0-1.5 times the plasma volume (PV), which corresponds to removal of 63–72% of the plasma constituents. Treatment dose, defined as the plasma volume to be exchanged to achieve the desired clinical outcome for various diseases, are determined by the ASFA Guidelines.
Methods
The study (NCT06382675) is an interventional, single arm study assessing the clinical performance and safety of the new plasma filter PX2 (Fresenius Medical Care, Bad Homburg, Germany), applied for extracorporeal blood purification during plasmapheresis therapy. In preclinical studies, the filter showed excellent hemocompatibility.
272 TPE treatments, performed according to the clinical practice, will be evaluated, by assessing e.g., the delivered treatment dose, sieving coefficients of plasma constituents, and the incidence of hemolysis, clotting or clogging of the filter. Blood and filtrate samples are drawn before, after every 0.5 PV treated and at the end of the treatment.
The performance benchmark – defined as achieved absolute plasma separation volume in comparison to planned plasma separation volume – will be used to analyze if the new filter will be able to deliver the treatment dose and thus the expected clinical outcome.
Results
The study is designed to clinically evaluate the PX2 plasma filter regarding sieving coefficients and safety. In addition, the influence of patients factors on TPE treatment success (delivery of treatment dose) will be assessed through subgroups analysis. The results of the subgroup analysis will be presented as descriptive analysis.
Conclusion
The study aims to evaluate the clinical performance and safety of a newly developed plasma filter. Moreover, the study aims to broaden the knowledge about patient factors influencing the treatment success.
Funding
- Commercial Support – Fresenius Medical Care Deutschland GmbH